Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab alone for pMMR endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

All participants receive an initial induction phase of six three-week cycles of pembrolizumab combined with carboplatin plus paclitaxel or docetaxel. Participants whose disease does not progress after induction enter a maintenance phase and are randomly assigned to pembrolizumab with sacituzumab tirumotecan or pembrolizumab alone. Participants whose disease progresses may enter a subsequent treatment phase and be randomized to pembrolizumab plus sacituzumab tirumotecan or sacituzumab tirumotecan alone. The main goal is to compare length of time without disease progression and overall survival between the randomized groups.

Why it matters

Who can join: the full rules

Key inclusion criteria include but are not limited to:

* Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
* Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator
* Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment

Key exclusion criteria include but are not limited to:

* Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
* Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
* Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment
* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate

Where it's running

• University of South Alabama, Mitchell Cancer Institute ( Site 6033)
  Mobile, Alabama, United States Recruiting
• Alaska Women's Cancer Care ( Site 6036)
  Anchorage, Alaska, United States Recruiting
• CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014)
  Irvine, California, United States Recruiting
• University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)
  Orange, California, United States Recruiting
• Sansum Clinic (Ridley Tree) ( Site 8007)
  Solvang, California, United States Recruiting
• John Muir Health Cancer Center ( Site 6028)
  Walnut Creek, California, United States Recruiting

+221 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.